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Ketogenic Diet Variations for Type 2 Diabetes and Obesity (KETO-IM Trial)

N/A

Recruiting

Led By Catherine Chan, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

KETO-IM Trial Summary

This trial tests the effects of two KETO diets and a low-fat diet on CVD risk, inflammation, and immune function in people at risk of or with type 2 diabetes. Results will be measured at 3 and 6 months.

Who is the study for?

This trial is for adults with obesity or overweight and HbA1C levels at or above 5.7%, indicating high blood sugar, which can be a sign of prediabetes or diabetes. It's not suitable for individuals with certain cholesterol or triglyceride disorders, those undergoing menopause, on dialysis, transitioning transgender individuals, pregnant women, or anyone whose diet wouldn't allow them to follow the study's nutritional guidelines.Check my eligibility

What is being tested?

The study is testing three diets: a ketogenic diet supplemented with saturated fat (Keto-SAT), a ketogenic diet supplemented with canola oil (Keto-CAN), and a low-fat diet (LFD). Participants will be randomly assigned to one of these diets to see how they affect heart disease risk factors like cholesterol and blood sugar levels as well as inflammation and immune function over periods of 3 and 6 months.See study design

What are the potential side effects?

Potential side effects may include changes in cholesterol levels due to different fat sources in the diets. The keto diets might cause digestive issues like constipation due to lower fiber intake. There could also be fatigue during initial adaptation to ketosis.

KETO-IM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of diets on LDL-cholesterol levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

Effect of diets on LDL-cholesterol levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months).

Effect of diets on plasma triglycerides levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

+1 more

Secondary outcome measures

Effect of diets on ApoB100 levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

Effect of diets on ApoB100 levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months).

Effect of diets on blood glucose levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

+9 more

Other outcome measures

Adherence to diet interventions using 24-hour dietary assessment tool

Change in fatty acid composition to confirm adherence to the diets at 3 months

Change in fatty acid composition to confirm adherence to the diets at 6 months

KETO-IM Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: KETO-SatExperimental Treatment1 Intervention

KETO diet supplemented with butter, coconut or palm oil (high in SFA).

Group II: KETO-CanExperimental Treatment1 Intervention

KETO diet supplemented with Canola oil (high in MUFA and omega-3 FA).

Group III: Low fat diet (LFD)Active Control1 Intervention

Low fat diet supplemented with whole grains and other low-fat foods.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,959 Total Patients Enrolled

Catherine Chan, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

Keto-CAN (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05681468 — N/A

Type 2 Diabetes Research Study Groups: KETO-Can, KETO-Sat, Low fat diet (LFD)

Type 2 Diabetes Clinical Trial 2023: Keto-CAN Highlights & Side Effects. Trial Name: NCT05681468 — N/A

Keto-CAN (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681468 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants aged 55 or younger eligible for the experimental trial?

"This trial is only open to participants aged between 18 and 70. There are 93 medical trials, however, that can accept minors while 878 studies recruit people over the age of 65."

Answered by AI

Who is qualified to partake in this research project?

"This clinical trial requires 175 participants with type 2 diabetes, ranging in age from 18 to 70. Other essential criteria include being overweight or obese and having an HbA1C level higher than 5.7% at the screening stage."

Answered by AI

Is this trial actively seeking participants?

"Clinicaltrials.gov reveals that this particular trial, which initially opened its doors on March 1st 2023, is no longer accepting participants at present. However, the platform still features over 1100 other medical trials actively seeking patients."

Answered by AI

What aims does this research endeavor seek to accomplish?

"The aim of this three-month clinical trial is to observe the effect of different diets on plasma triglyceride levels. This will be done by comparing groups at 6 months post intervention (e.g., control low fat diet and two keto groups) as well as monitoring changes within each group from baseline to 6 months. Additionally, researchers are looking into the effects that these diets have on glucose and insulin levels which will also be assessed via blood samples in a fasting state utilizing Roche Cobas c503 machinery for glucose measurements and Roche Cobas e801 equipment for insulin assessments. These will again be measured between and within respective groups over 3 month periods"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources

2023. "Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681468.